This role is critical to ensuring regulatory alignment and operational continuity across quarterly release cycles and long-term system lifecycle management
Job Summary
This role is critical to ensuring regulatory alignment and operational continuity across quarterly release cycles and long-term system lifecycle management.
You will collaborate with cross-functional teams including Quality, IT, and Product to ensure compliance with SDLC-SOP-09 and CSA methodology.
Join a global healthcare biopharma company with a 130-year legacy of success backed by ethical integrity and a mission to achieve new milestones in global healthcare.
Matching Summary
This role is critical to ensuring regulatory alignment and operational continuity across quarterly release cycles and long-term system lifecycle management.
Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
GMP validation experience
SDLC execution expertise
Jira and Confluence proficiency
FDA and EMA regulatory knowledge
Risk-based validation approaches
Nice-to-have
Manufacturing intelligence platform support
SOP authorship and lifecycle sustainment
Cross-functional stakeholder engagement
Automated compliance tools knowledge
Digital transformation collaboration
Key Requirements
Bachelor's degree in Computer Science, Engineering, or Life Sciences
3+ years of experience in GMP validation or CSV/CSA methodologies
Strong understanding of FDA and EMA regulatory frameworks